Quality Management

Quality Management at bioskin

Quality is a hallmark of bioskin's services. One of the most important roles of our quality management is to instil the principals of GCP and the importance of compliance at every step of the clinical trial process in our employees. To ensure that our work holds to the highest standards, all studies and processes are regularly subject to internal audits. Further, all of our partners and vendors are subject to ongoing quality assessment and audits.

As a modular service, bioskin offers independent audits for system/vendor audits or site audits within trials not conducted by bioskin.

Bundesverband Medizinischer Auftragsinstitute

bioskin is proud to be a member of the Federal Association of Contract Research Organizations (Bundesverband Medizinischer Auftragsinstitute, BVMA).  A CRO must meet the high quality prerequisites set by the BVMA to be a member. In order to ensure that these quality standards are met and maintained, each member CRO must undergo an independent system audit carried out by a BVMA appointed external organization before acceptance and again every three years.

During this audit all of bioskin’s systems, procedures, practices and documentation were assessed to ensure compliance with Good Clinical Practice (ICH GCP), relevant national and international requirements and standards, and generally accepted good practices.